Not yet recruitingNAINTERVENTIONAL

The Effect of Inulin Supplementation on Colorectal Surgery Outcomes

This research is investigating if a natural plant fibre called inulin can improve how well your bowel heals after surgery for bowel cancer. When parts of the bowel are joined back together, sometimes there can be a leak, which is a serious problem. Researchers believe that the 'good' bacteria in your gut play a big role in healing, and inulin might help these bacteria. This study aims to find out if it's practical to conduct a larger trial to see if taking inulin before surgery helps prevent these leaks, reduces other issues, and affects the gut bacteria. It's an important step towards better ways to support recovery after bowel cancer surgery.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

Start

01 Aug 2023

Estimated completion

01 Aug 2028

Anastomotic Complication

What is this study about?

When someone has surgery for bowel cancer, the surgeon removes the cancerous part and then carefully joins the two healthy ends of the bowel back together. This joining is called an 'anastomosis'. Sometimes, in a small number of people, this new join can develop a leak. This can be a very serious problem, leading to infections and a longer hospital stay, or even worse complications.

Scientists have been looking into what helps the bowel heal properly after surgery. They've found that the tiny living organisms in our gut, often called 'gut bacteria' or 'gut microbiome', seem to play a really important role. They think that if these good bacteria are healthy and plentiful, they might help the bowel mend itself more effectively. Inulin is a natural fibre, found in many plants, which acts like food for these good gut bacteria. Lab studies have hinted that inulin could boost bowel healing.

Because this idea looks promising, this study wants to see if we can safely and effectively test inulin in people having bowel cancer surgery. It's designed to be a 'pilot project' – a smaller study to work out the best way to do a bigger one later. The main goal is to check if patients can easily take inulin before surgery, and to get early information on whether it helps with healing, avoids leaks, and changes the gut bacteria. This research could open doors to new ways of helping patients recover better after bowel cancer surgery.

Key takeaways

This study explores using a natural fibre, inulin, to help bowel healing after cancer surgery.
The main goal is to reduce serious complications like bowel leaks.
Inulin might work by supporting healthy 'gut bacteria'.
It's a pilot study to see if a larger trial is possible.
Participants will be randomly assigned to receive inulin or a dummy supplement (placebo).
All care will be carefully monitored by the study team.

Who may be eligible?

This study is looking for adults who are planning to have surgery for bowel cancer. You would need to be well enough for a planned, rather than emergency, operation.

There are certain reasons why you might not be able to join the study. For example, if you've recently taken antibiotics (unless it was the usual dose given just before surgery), had recent bowel surgery, or already have a stoma (a bag for waste). Also, if you have certain conditions like active asthma or a specific inherited condition called familial adenomatous polyposis, you wouldn't be able to take part.

The research team will carefully check your medical history to make sure the study is a safe and suitable option for you. If you're interested, they'll discuss all the details with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you having surgery for bowel cancer?
Is your surgery planned (not an emergency)?
Have you avoided antibiotics in the last 4 weeks (besides the usual pre-surgery dose)?
Do you currently not have a stoma (a bag for waste)?
Have you not had other bowel surgery in the last 4 weeks?
Do you not have active asthma or a specific inherited bowel condition called familial adenomatous polyposis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups: either you'll receive the inulin supplement or a 'placebo' (a dummy supplement that looks exactly like inulin but has no active ingredient). You won't know which one you're taking, and neither will your doctors or the research team – this is to make sure everyone is treated fairly and the results are unbiased.

Before your surgery, you would take the assigned supplement for a set period. Throughout the study, the research team would monitor your health and recovery closely. This includes checking how your bowel heals, looking at your gut bacteria through samples like stool, and assessing any issues or complications after surgery. There would also be a follow-up to see how you're doing in the longer term regarding your recovery and cancer.

The specific details of how long you'd take the supplement for, and the exact number of visits or samples needed, would be explained fully if you consider joining. You will be given all the information to help you understand what is involved.

Potential risks and benefits

Taking part in this study might offer a potential benefit if inulin helps improve your bowel healing and reduces the risk of serious complications like leaks after surgery. However, because this is a pilot study, we don't know for sure if inulin will have this effect or if there are other benefits. There might be some mild side effects from taking inulin, such as bloating or gas, but these are usually temporary. The research team will monitor you closely for any unwanted effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Centre hospitalier de l'Université de Montréal (CHUM)
Verified postcode
Montreal, Canada

Common questions

What is inulin?

Inulin is a natural fibre found in many plants, like chicory root, onions, and garlic. It's known to help 'good' bacteria in our gut grow and thrive.

What is a 'placebo'?

A placebo is a substance that looks exactly like the study supplement but doesn't contain any active medicine. It's used to compare against the real supplement to see if the active ingredient truly makes a difference.

Why is it important to prevent leaks after bowel surgery?

Leaks at the join in the bowel are a serious complication that can cause severe infections, longer hospital stays, and can even be life-threatening. Preventing them is very important for patient recovery.

Will I know if I'm taking inulin or the placebo?

No, neither you nor your doctors or the research team will know which you are taking. This is called 'triple-blind' and helps ensure the study results are fair and accurate.

Who is funding this study?

The information provided doesn't specify the funding source for this trial.

How to find out more

Carole Richard, MD

carole.richard.med@ssss.gouv.qc.ca 514 890-8000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.